Articles

Learn more about the mandatory General Safety and Performance Requirements or GSPR needed when placing a medical device on the EU market. These GSPR can be found in Annex I of the Medical Device Regulation.

The Medical Device Regulation (MDR) implemented by the European Union (EU) places significant emphasis on the role of the Person Responsible for Regulatory Compliance (PRRC). In addition to their responsibilities, the MDR outlines specific requirements for the education and

The Medical Device Regulation (MDR) is a comprehensive regulation aimed at ensuring the safety and effectiveness of medical devices within the European Union (EU). One crucial requirement of the MDR is the appointment of a Person Responsible for Regulatory

To achieve the purpose of the manufacturer’s PMS system, the manufacturer must have a PMS plan. This is also stated in Article 84 of the MDR. But article 84 basically only references Annex III, which is the annex that describes the requirements on the technical documentation of the PMS.  

Post-market surveillance reporting requirements are different depending on the classification of the devices the PMS system covers. This article provides an overview of PMS reporting based on medical device classification.

Dealing with post-market surveillance (PMS) is important for medical devices on the EU market. It is also one of the focus areas of the notified bodies. This makes it essential for all manufacturers and others working within the medical device industry.

Most manufacturers consider the notified body conformity assessment the most challenging part of the CE marking process. This article outlines the general setup of the conformity assessment procedure for medical device manufacturers.

Every stakeholder within the MDR has their own roles to fulfil, and in the medical device industry, it is of great importance to know exactly what those roles are, as is to know the difference between the stakeholders and economic operators.